Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP. However, today, there are no international recommendations concerning the long-term use of these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in ITP management. But our center along with many other research centers, have reported unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In these retrospective studies, more than 20 % of patients were able to achieve prolonged remission. The purpose of this study is to demonstrate that a substantial proportion of ITP patients may achieve a prolonged response after Tpo-RA discontinuation. The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new therapy will be based on the clinician's judgment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
a standardized strategy of dosage reduction will be implemented according to a predetermined scheme on persistent and/or chronic ITP patients who have previously achieved a stable and prolonged (\> 2 months) complete response (platelets counts \> 100 x 109/L) period on Tpo-RA treatment.
Henri-Mondor Hospital
Créteil, France
The proportion of patients achieving an overall response (complete response and response) at week 24 (6 months). The criteria of response will be defined according to international terminology
the criteria of response will be defined as the following: * Response (R) will be defined as sustained platelet count \>30x109/L in the absence of bleeding or use of any other ITP directed therapies between the week 0 (discontinuation) and week 24. * Complete response (CR) by a platelet count \> 100x 109/L in the absence use of any other ITP directed therapies between week 0 and week 24. * Patients will be considered as being non-responders (NR) if: 1. Their platelet count is \< 30 x 109/L between week 0 and week 24, but also, in the setting of this study if: 2. They need a rescue therapy (a new course of corticosteroids and/or intravenous immunoglobulin) after inclusion.
Time frame: week 24 (6 months)
The rate of overall response after Tpo-RAs discontinuation
response and complete response
Time frame: 24 and 52 weeks
The duration of overall response after Tpo-RAs discontinuation.
response and complete response
Time frame: 24 and 52 weeks
The number of bleeding events during the reduction period and along the study period at weeks 4, 8, 12,24,36, 52
Safety assess of Tpo-RAs discontinuation
Time frame: at weeks 4, 8, 12,24,36, 52
The rate of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation at one year
Rate of the response in case of relapse
Time frame: 52 weeks
The delay of the response to a new course of Tpo-RAs in case of relapse after Tpo-RAs discontinuation
Delay of the response in case of relapse
Time frame: 52 weeks
To identify predictive factors, for overall prolonged response
Search for predictive factor of response
Time frame: Weeks 24
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